Hilden, Germany, and Germantown, Maryland, September 08, 2020 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced plans to launch a rapid portable test that can detect SARS-CoV-2 antigens in people with active infections in less than 15 minutes and process on average around 30 swab samples per hour using a small digital detection system.
The Access Anti-SARS-CoV-2 Antigen Test, which is expected to become available in the fourth quarter of 2020, is designed for environments that require a high volume of fast and accurate test results. The portable test offers a new combination of speed and scale that marks an important step towards decentralized mass testing that health authorities all over the world have been urgently seeking.
The Access Anti-SARS-CoV-2 Antigen Test extends the partnership with Ellume, an Australian digital diagnostics company. It is the second QIAGEN COVID-19 test to make use of Ellume’s digital eHub and eStick system. QIAGEN in August announced the Access Anti-SARS-CoV-2 Antibody Test that uses the same devices.
Two versions of the Antigen Test are scheduled for US launch in the fourth quarter – one for labs and one for point-of-care (POC) use. QIAGEN will apply for FDA Emergency Use Authorization and seek CE-IVD registration in Europe. A CLIA Waiver in the US would allow the POC version to be used in settings like airports or stadiums.
Feasibility tests have shown the Access Antigen Test to have a sensitivity of at least 90% and a specificity of 100%.
“The Access Antigen Test is fast, easy to use and cost-effective and will be a valuable tool to address the so far unmet high-volume testing needs for SARS-CoV-2 antigens in situations where time is of the essence,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “It will deliver highly accurate results and will complement the gold-standard PCR tests used for detection of active COVID-19 infection. PCR tests offer a high level of diagnostic accuracy but are time-consuming and lab-bound.”
The Access Anti-SARS-CoV-2 Antigen Test uses the QIAGEN eHub that was launched in August, a rugged portable machine, to analyze nasal-swab samples from up to eight symptomatic people at once. The easy-to-use eStick uses nanoparticle fluorescent detection technology to flag the SARS-CoV-2 nucleocapsid protein, an antigen present on the surface of the virus. The device delivers negative results in 15 minutes – and in as little as three minutes in the case of a strong positive.
This means one eHub can process on average about 30 tests per hour with the possibility for one user to operate more than one eHub. As Access Anti-SARS-CoV-2 Antibody test, released late August, also uses the device, lab professionals will be able to run tests to detect both previous and active infections on one device at the same time – with each testing slot operating independently of the others. Knowledge of past and present infections is essential to understanding and inhibiting the spread of the disease.
The Antibody Test strengthens QIAGEN’s robust COVID-19 testing portfolio that addresses customer needs from fundamental research to diagnostics. The Access Anti-SARS-CoV-2 Antigen Test and the Access Anti-SARS-CoV-2 Antibody Test run on the eHub platform that QIAGEN is using for Access QuantiFERON-TB. This is a new solution still in development that will help low-resource and high-burden regions diagnose latent tuberculosis infection.
QIAGEN employees are addressing the urgent demand for testing solutions needed in the global response to the coronavirus pandemic. They are massively ramping up production capacity and building the most comprehensive portfolio of solutions for COVID-19 testing.
These include viral RNA extraction for use on QIAGEN’s QIAcube, QIAsymphony and EZ1 platforms as well as third-party instruments; a range of PCR tests on the QIAstat-Dx and NeuMoDx systems that enable COVID-19 detection while analyzing samples at the same time for other respiratory infections; and the Access Anti-SARS-CoV2-Antbody Test for detection of immune response in people who have been exposed to the virus in the past.
QIAGEN also provides universal next-generation sequencing (NGS) solutions for research use with any sequencer, in particular gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus And QIAGEN is also providing reagents sold to other companies for use in their own COVID-19 tests.
QIAGEN products are being used for the development of vaccines against COVID-19. QIAGEN expects that the availability of vaccines will drive ongoing demand for testing as the immune response in the population will have to be assessed and monitored.
Further information on QIAGEN’s response to the coronavirus outbreak can be found here.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Forward-Looking Statement
Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of QIAGEN’s new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).